Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma

Study acronym: ANTELOPE
StatusActive, Not Recruiting
PhasePhase 4
Started

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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Feb 2026 to Mar 5, 2026
    • Site details revised at 36 of 36 sites
    v8
  2. Minor Study sites: 31 to 36
    • Primary completion date: Oct 2025 to Feb 2026
    v7
  3. Minor Eligibility criteria expanded, about 134 words
    • Site details revised at 4 of 31 sites
    v6
  4. Minor Site details revised at 13 of 31 sitesv5
  5. Minor Study sites: 29 to 31v4
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  1. Minor Study sites: 23 to 29
    • Start date changed from estimate of Nov 2023 to Dec 6, 2023
    v3
  2. Notable Phase: Phase 2 to Phase 4
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2023 to Nov 2023
    • Study sites: 0 to 23
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.
Trial Details
NCT Number NCT05689671
Lead Sponsor Nikolaj Frost MD
Collaborators: Roche Pharma AG, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions
(from sponsor)
Non-Small Cell Lung Cancer Metastatic
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov